NDC Code(s) : 52268-201-01
Packager : Braintree Laboratories, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

SUTABsodium sulfate, magnesium sulfate, and potassium chloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52268-201
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM SULFATE(UNII: 0YPR65R21J)
(SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) 		SODIUM SULFATE17.75 g
MAGNESIUM SULFATE ANHYDROUS(UNII: ML30MJ2U7I)
(MAGNESIUM CATION - UNII:T6V3LHY838) 		MAGNESIUM SULFATE ANHYDROUS2.7 g
POTASSIUM CHLORIDE(UNII: 660YQ98I10)
(POTASSIUM CATION - UNII:295O53K152) 		POTASSIUM CATION2.25 g
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
SODIUM CAPRYLATE(UNII: 9XTM81VK2B)
ETHYLENE GLYCOL(UNII: FC72KVT52F)
POLYVINYL ALCOHOL GRAFT POLYETHYLENE GLYCOL COPOLYMER (3:1; 45000 MW)(UNII: 23ZQ42JZZH)
Product Characteristics
Color white (white to off-white) Score no score
Shape OVAL Size 19 mm
Flavor Imprint Code S24
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52268-201-012 in 1 KIT 11/10/2020
112 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA213135 11/10/2020

LABELER - Braintree Laboratories, Inc.(107904591)

Establishment
Name Address ID/FEI Business Operations
Braintree Laboratories, Inc. 617357954 manufacture(52268-201), analysis(52268-201)

PRINCIPAL DISPLAY PANEL

Principal Display Panel Carton Label

NDC 52268-201-01

Please see www.sebelapharma.com for patent information.

SUTAB
(sodium sulfate, magnesium sulfate, and potassium chloride)
Tablets
1.479g/0.225g/0.188g

NOTE TO PHARMACIST:Inform patients to REMOVE AND DISCARD the DESICCANTfrom both medication bottles before SUTAB ingestion.

This carton contains:

2Bottles of 12 tablets each
116-ounce cup
1Patient booklet
Booklet includes:
1. Instructions for Use
2. Full Prescribing Information
3. Medication Guide

Both 12-tablet bottles are required for a complete preparation.

©2020 Braintree Laboratories Inc. All rights reserved. OCT 2023

SUT20101

Rx only

Braintree
A PART OF SEBELA PHARMACEUTICALS

Carton

PRINCIPAL DISPLAY PANEL

Principal Display Panel Bottle Label

NDC 52268-200-01
Rx only

SUTAB
(sodium sulfate, magnesium sulfate, and potassium chloride)
Tablets
1.479g/0.225g/0.188g

 REMOVE and DISCARD DESICCANT

This bottle contains 12 tablets and a desiccant.

Both 12-tablet bottles are required for a complete preparation.

Store at 25°C (77°F);
excursions permitted
15-30°C (59-86°F)

Recommended Dosage:
See full prescribing information

©2020 Manufactured by Braintree Laboratories, Inc. Braintree, MA

Bottle Label